| CTRI Number |
CTRI/2026/01/100335 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Evaluation of Anxiety Levels in children Patients using Distraction Technique with Birds and bird video |
|
Scientific Title of Study
|
Comparative evaluation of anxiety in children during class I restoration using distraction technique with live and virtual birds: a clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Julita Joseph |
| Designation |
postgraduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, 4th floor, room no. 8 Bangalore KARNATAKA 560068 India |
| Phone |
09990565773 |
| Fax |
|
| Email |
julitajoseph23@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bharath Vardhana |
| Designation |
postgraduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, 4th floor, room no. 8 Bangalore KARNATAKA 560068 India |
| Phone |
9886588595 |
| Fax |
|
| Email |
bharath.dentist@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Julita Joseph |
| Designation |
postgraduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry, 4th floor, room no. 8 Bangalore KARNATAKA 560068 India |
| Phone |
09990565773 |
| Fax |
|
| Email |
julitajoseph23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Julita Joseph |
| Address |
The Department of Pediatric and Preventive dentistry
The Oxford Dental college,
Bangalore- 560068 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Julita Joseph |
The oxford Dental College |
Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
The Oxford Dental College,
Bangalore
The Oxford Dental college Bangalore KARNATAKA |
09990565773
julitajoseph23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Julita Joseph |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children coming for dental checkups |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6-8 who which fulfill the criteria will be selected. Prior written consent for performing treatment will be obtained from the parents.
The demographic details, brief case history and clinical findings of each patient will be recorded.
Following clinical examination, the Animated Emoji Scale (AES) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) will be explained to the patient.
The children will be randomly divided into two groups of 15 each:
Group 1:the treatment will be performed in the presence of the birds and anxiety level will be measured at baseline, during treatment and after treatment. Animated Emoji Scale (AES scale) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) would be used at the start and completion of the treatment.
Group 2: the treatment will be performed in the presence of the audiovisual of birds and anxiety level will be measured at baseline, during treatment and after treatment. Animated Emoji Scale (AES scale) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) would be used at the start and completion of the treatment.
|
|
| ExclusionCriteria |
| Details |
1. Children who have phobia towards birds
2. Children who have respiratory problems.
3. Children who have allergy to dust
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effect of presence of live birds as distraction to reduce anxiety in pediatric patients.
2. To compare the effect of presence of audiovisual of birds in reducing anxiety in pediatric patients.
|
assessment will be done
1. before treatment
2. during treatment
3. after treatment |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Distraction
techniques in Pediatric Dentistry are crucial for managing anxiety and fear in
young patients, ensuring a positive dental experience. Dentistry
exposes patients to an environment and particular experiences that trigger a
natural response of fear in many people. Dental anxiety can be defined as a
state where an individual is evoked and prepared for something to happen, with
a non-specific feeling of apprehension associated with abnormal conditions.
Dental anxiety is majorly seen in children, Fear and anxiety in children might
trigger behavioural management problems during dental appointments manifesting
as inability or difficulty to cooperate and engage during dental treatment and
delivery of oral care advice. There are various methods of
distraction that dental professionals can employ, tailored to the child’s age,
preferences, and level of anxiety. Visual distractions, like cartoons or movies
played on a screen, are popular in pediatric settings, capturing the child’s
attention and making them less aware of the treatment environment. Auditory
distractions, such as listening to music or stories through headphones, can
also help mask potentially distressing dental sounds, like the noise of dental
drills. Additionally, interactive distractions like handheld video games,
tablets, or virtual reality (VR) devices offer immersive experiences that keep
the child engaged, often minimizing their anxiety considerably.
Using live birds as a distraction
technique in dental treatment is an innovative and natural approach that can
help ease patient anxiety, especially in children. Birds, with their vibrant
colors, gentle chirping, and playful behaviour, offer a unique sensory
distraction that can calm nerves and engage patients’ attention. The presence
of birds—whether in a viewing area near the waiting room, an aviary in the
office, or through video screens with soothing bird imagery and sounds—can provide
a comforting and visually engaging experience that diverts attention away from
the treatment. |